Composition of fentanyl citrate oral solid transmucosal dosage form, excipient and binding material therefore, and methods of making

摘要

A process of preparing a highly uniform oral transmucosal lozenge of fentanyl citrate (a "fentanyl lollipop") provides uniform distribution of the drug. The content uniformity between the lozenges and uniform distribution of the drug within a lozenge is achieved by dry mixing a micronized drug of a particle size of about one to ten microns with at least one major excipient, such as a dextrose, having cavities and pores on its surface after pressing into the lozenge shape. The major component of the lozenge can be a binding material prepared with a mixture of dextrose hydrate, food grade starch and water. This binding material has better strength to bind the stick to the lozenge due to stronger cross-linked matrix formation between the lozenge and the binding material.